Eli Lilly has shared one-year histologic outcomes from a phase 3 study of its interleukin-23p19 antagonist mirikizumab in Crohn’s disease.
The late-stage VIVID-1 trial evaluated the safety and efficacy of mirikizumab compared with placebo or Johnson & Johnson’s Stelara (ustekinumab) in adults with moderately to severely active Crohn’s disease, with or without previous biologic failure.
Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects almost one in every 100 people in the US.
The condition causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention.
Lilly’s mirikizumab already holds approvals to treat moderately to severely active cases of ulcerative colitis, another of the two main forms of IBD, in adults under the brand name Omvoh.
According to the results from VIVID-1 presented at this year’s United European Gastroenterology Week, 58.2% of mirikizumab-treated patients in the overall population achieved histologic response at week 52, compared to 48.8% of those receiving Stelara.
Mirikizumab showed greater histologic response at week 52 in patients with active histologic disease at baseline and with at least one prior biologic failure, at 56.5% versus 41.3%. Additionally, 39.6% of patients in this population receiving mirikizumab achieved endoscopic-histologic response at week 52, compared to 27.8% of those on Stelara.
Lilly’s drug also achieved nominally statistically significant improvements across all histologic and histologic-endoscopic endpoints versus placebo at weeks 12 and 52.
Mark Genovese, senior vice president of Lilly Immunology development, outlined that the company is the first to report “rigorous histologic and endo-histologic outcomes” in Crohn’s disease that align with the recently published European Crohn’s and Colitis position statement on mucosal histopathology.
“This data also broadens our understanding of the underlying inflammation that drives Crohn’s disease and may represent a critical step forward in helping health care providers and their patients make more informed choices about treatment,” Genovese added.
The company has already submitted marketing authorisation applications for mirikizumab in Crohn’s disease around the world, including in the US and EU.